R-Biopharm is IVDR certified

Share

The quality management system of the biotechnology company complies with the European in-vitro Diagnostic Regulation (IVDR)

R-Biopharm's quality management system is IVDR certified
R-Biopharm's quality management system is IVDR certified

Darmstadt, June 30, 2022 – Quality orientation is an integral part of the culture and processes at R-Biopharm AG. The biotechnology company from southern Hesse thus ensures that quality is integrated throughout the entire company and continually improved in order to deliver reliable products for the health of patients in the long term. The family owned company has regular audits conducted to check the suitability and functionality of all quality-related elements. In fall 2021, R-Biopharm was one of the first companies to undergo the comprehensive audit for the new IVDR certification by TÜV SÜD and has now received the certificate.

What has become mandatory for manufacturers of in vitro diagnostics throughout Europe after a five-year transitional phase at the end of May 2022 in accordance with the European regulation for in vitro diagnostics has already been proven by the biotechnology company in fall 2021. The IVDR certification will ensure that R-Biopharm can continue to offer its clinical in vitro diagnostics in Europe and worldwide according to the stricter legal requirements. The simultaneous recertification according to MDSAP (Medical Device Single Audit Program), ISO 9001:2015, and DIN EN ISO 13485:2016 as well as the Directive for in-vitro diagnostics 98/79/EC makes R-Biopharm one of only few companies worldwide that are currently certified according to these four standards.

With its holistic quality management system, R-Biopharm ensures that normative and regulatory requirements are fulfilled from the development to the application of products and that correspondingly high-quality standards apply. “In our company, quality is not the action of a few but rather the attitude of all our employees”, says board member Dr Hans Frickel. “Our focus on quality is also highly relevant internally. By applying quality-oriented standards, we can detect risks and errors, efficiently design working methods, identify our strengths and potentials, and derive needs for action that will help us to continually improve”.

Keywords

Contacts

Simone Feiler
Head of Corporate Brand
Communication:
https://r-biopharm.com
https://r-biopharm.com/contact/
https://r-biopharm.com/news-press/download-gallery/

Images

R-Biopharm's quality management system is IVDR certified
R-Biopharm's quality management system is IVDR certified
Download

Links

About R-Biopharm AG

R-Biopharm AG
An der neuen Bergstraße 17
64297 Darmstadt, Germany

Tel:0 61 51 - 81 02-538https://r-biopharm.com

Subscribe to releases from R-Biopharm AG

Subscribe to all the latest releases from R-Biopharm AG by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from R-Biopharm AG

R-Biopharm starts commercialization of the fully automated RIDA®UNITY system for real-time PCR in molecular diagnostic laboratories19.7.2022 09:00:00 EEST | Press release

Darmstadt, July 19, 2022 – As a fully integrated solution, the new and completely automated RIDA®UNITY system combines sample extraction, PCR setup, real-time PCR and result evaluation in a common workflow. The biotechnology company R-Biopharm AG announced today that it has received the CE mark and will begin selling the new, fully automated RIDA®UNITY system for molecular detection of infectious diseases throughout Europe. "With the RIDA®UNITY system, R-Biopharm is purposefully taking the path from a provider of individual solutions to a system provider in the field of molecular diagnostics," stated Christian Dreher, CEO of R-Biopharm. "We are very happy to make this system solution available to all molecular biology laboratories throughout Europe." Unique combination of different tools The RIDA®UNITY system combines the various steps in the analysis of patient samples into an integrated workflow – nucleic acid extraction, PCR setup, subsequent real-time PCR and the evaluation of the

R-Biopharm receives approval of COVID-19 test in the UK under CTDA legislation7.12.2021 14:54:19 EET | Press release

Darmstadt, 7 December 2021 – R-Biopharm, an international specialist in clinical diagnostics, announces that the company’s RIDA®GENE Flu & SARS-CoV-2 multiplex test (PG6825) has been approved in the UK under the UK Health Security Agency’s Medical Devices (Coronavirus Test Device Approvals) Regulations 2021 (“CTDA”). R-Biopharm will now work to resume the sale of the product in the UK.